Actinic Keratosis Clinical Trial
Official title:
Efficacy of Iontophoresis-assisted Ablative Fractional Laser Photodynamic Therapy With Short Incubation Time for the Treatment of Actinic Keratosis: 12-month Follow-up Results of a Prospective, Randomised, Comparative Trial
Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).
Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment
of actinic keratosis (AK). Many strategies have been studied to improve the production of
protoporphyrin IX (PpIX), to improve efficacy of PDT. Pre-treatment of the skin with
fractional laser resurfacing is a novel alternative technique to improve the efficacy of PDT
for AK. Our previous studies showed that ablative fractional laser-primed PDT (AFL-PDT)
offered higher efficacy than conventional MAL-PDT in the treatment of many diseases, such as
AK, actinic cheilitis, Bowen's disease and basal cell carcinoma.1-4 Iontophoresis can be
another method to improve efficacy of PDT. Iontophoresis is a transdermal drug-delivery
technique which uses a mild electric current to enhance the transport of ionic species
across membranes. Iontophoresis has been widely used to enhance drug delivery. Mizutani K et
al.5 reported 5 AK patients successfully treated with direct-current pulsed
iontophoresis-assisted 5-aminolevulinic acid (ALA)-PDT. Boddé HE et al.6 studied
iontophoretic transport of ALA quantitatively in vitro and demonstrated enhanced transport
of ALA by iontophoresis.
Until now, appropriate incubation time for AFL-PDT has not been elucidated. In our previous
study, we investigated the efficacy of AFL-PDT with a short incubation time.7 Although
AFL-PDT with a short incubation time (2 h) showed enhanced efficacy than conventional
MAL-PDT with the standard incubation time, standard AFL-PDT with 3-h incubation time showed
significantly higher efficacy than AFL-PDT with a short incubation time.
The aim of our study was to evaluate efficacy of iontophoresis in AFL-PDT for AK treatment.
Consequently, we compared efficacy, recurrence rate, cosmetic outcome and safety between
iontophoresis-assisted AFL-PDT with 2-h incubation time and conventional AFL-PDT with 2-h
and 3-h incubation times.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03013647 -
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization
|
N/A | |
| Completed |
NCT02674048 -
Metvix Daylight PDT in Actinic Keratosis
|
||
| Completed |
NCT02239679 -
Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy
|
Phase 2 | |
| Completed |
NCT02421471 -
PMS to Evaluate the Safety and Efficacy of Picato® Gel
|
||
| Completed |
NCT01686152 -
Study Comparing Imiquimod Cream, 3.75% to Zyclara® (Imiquimod) Cream, 3.75% in the Treatment of Actinic Keratosis
|
Phase 3 | |
| Completed |
NCT01444989 -
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
|
N/A | |
| Completed |
NCT01449513 -
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
|
Phase 1 | |
| Terminated |
NCT01525329 -
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
|
Phase 3 | |
| Terminated |
NCT01203878 -
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
|
Phase 4 | |
| Completed |
NCT00989313 -
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study
|
Phase 3 | |
| Completed |
NCT00306800 -
Metvix PDT Versus Vehicle PDT With Aktilite CL128 Lamp in Patients With Actinic Keratosis on the Face and Scalp
|
Phase 3 | |
| Completed |
NCT00375739 -
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
|
Phase 2 | |
| Completed |
NCT03285490 -
A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
|
Phase 3 | |
| Completed |
NCT03319251 -
Biomarker Database Registry for Photodynamic Therapy
|
||
| Completed |
NCT02866695 -
Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
|
Phase 4 | |
| Completed |
NCT02952898 -
Study Comparing GDC 695 and Diclofenac Sodium Gel, 3% in Subjects With Actinic Keratoses
|
Phase 3 | |
| Completed |
NCT02984072 -
Menthol for PDT Pain Relief
|
Phase 4 | |
| Recruiting |
NCT03684772 -
Topical Ionic Contra-Viral Therapy in Actinic Keratosis
|
Phase 2 | |
| Completed |
NCT02878382 -
Potential Impact of Patient Vitamin D Status in AK Response to MAL-PDT
|
N/A | |
| Completed |
NCT02938715 -
Pilot Study of the Pragmatic Use of Mobile Phone Based Follow up of Actinic Keratoses Treated With Topical 5-fluorouracil
|
N/A |